Regulatory Consultant

£40 - 50 per hour
Sep 13, 2016
Oct 11, 2016
Elise Lambeth
Result Type
Position Type
Full Time

 A well-known international pharmaceutical company with sites around the globe is looking to hire a Regulatory Consultant. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. 

Job Role:

  • Serves as a team member in the global regulatory team guiding the development of a biosimilar asset(s), and requirements for submission in EU, Switzerland & Australia.
  • Support the timely and effective registration and approval of biologics products within the biosimilar portfolio.
  • Provides input to global regulatory strategies, in particular capable of generating EU clinical development / CMC strategies for the biosimilar business. Ensures that regulatory strategies are focused on harmonized goals in line with the strategic goals for the biologic. Addresses regulatory issues related to the global development of biological products to support EU submissions including timely compilation of global core dossiers.

Role Responsibilities:

  • To develop and support EU regulatory strategies as part of the global strategy to support the registration of the biosimilar portfolio and lifecycle changes, and analyzes risk vs. benefit in these strategies.
  • Member of the global regulatory sub team contributing regulatory advice to global project teams to inform CMC development in R & D, and/or clinical activities and ensure the generation of high quality data to support product registrations across the globe. May serve as a lead CMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies.
  • Interacts with EU regulatory authorities (EMA and other EU/worldwide health authorities as necessary) including leading the preparation of agency briefing packages and meeting strategies. 
  • To effectively influence agency policy and legislation through attendance at key agency meetings, advisory and trade association meetings and through correspondence.
  • Support the preparation of global regulatory documentation and manage submission activities to meet business and agency milestones. Negotiates submission data requirements and deliverable dates with regulatory authorities, and internal technical teams. Author, with team members, key pieces of regulatory submissions.
  • Supports the preparation and maintenance of core dossiers for original applications and subsequent changes and coordinates responses to deficiency letters, with the assistance of local and regional regulatory colleagues. 
  • To maintain an awareness of EU/global regulatory requirements, legislation and guidance documents and assess the impact to the business and internal development programmes
  • Ensure regulatory plans are monitored, progress/variance communicated to the Global Regulatory Lead and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
  • Engage in appropriate activities in order to influence the regulatory environment through development of regulatory guidance, Agency contacts and Trade Associations as appropriate.
  • Supports implementation of systems, processes and procedures relating to regulatory strategy productivity


  • A higher degree may be an advantage but is not essential
  • Degree in pharmacy, biology, chemistry, pharmacology or related subject preferred
  • Strong technical background in drug development science
  • At least 5 years experience in regulatory affairs / CMC regulatory affairs ideally with specific biologics development experience and preferably spanning the entire lifecycle. Biosimilars experience would be an advantage but is not essential
  • Experience working directly with EMA and/or other health authorities
  • Personal traits would include ability to learn rapidly and strive for excellence. Flexible, adaptable and able to thrive in a dynamic fast paced environment

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